Pharmaceutical, Biotechnology, and Medical Device Commercialization
To succeed in today’s ever-changing and highly regulated consumer industries, companies need a legal partner who understands the big picture. From understanding how patent strategies affect market position to how utilizing third-party vendors impacts costs and company exposure, or how a particular activity may impact overall business operations, our attorneys provide clients with cross-disciplinary insight and practical legal advice to guide them through all stages of business from new product development through manufacturing, pricing, marketing, distribution, and advertising.
Contact the life science attorneys at Kendall PC today online or at (484) 414-4093. We serve clients throughout the United States and across the globe.
Regulatory Filings and Communications
The development, manufacturing, and marketing of a drug or medical device requires an in-depth understanding of the Food and Drug Administration (FDA) regulatory process, as well as the ability to interact effectively with FDA personnel. Our firm’s attorneys provide comprehensive counseling and advocacy on FDA drug and medical device matters, ranging from preparation of drug applications, product clearance and approval to post-marketing requirements, enforcement and compliance issues, and product promotion and advertising issues.
Our attorneys counsel and assist companies with the preparation and filing of:
- New Drug Applications (505(b)(1) and 505(b)(2))
- Abbreviated New Drug Applications (ANDAs)
- Investigational New Drug (IND) Applications.
Learn more about our Regulatory Services.
Promotional Review Committee (Medical, Legal & Regulatory Review Committee)
Successful life sciences companies understand that an effective PRC Committee is necessary not only to ensure accurate and non-misleading promotional materials, but also to reduce long-term litigation risks. We understand that no two products are alike, and each product presents a unique risk profile. Our attorneys have extensive experience serving as legal representatives on a variety of PRC teams and have advised clients on a wide range of prescription drugs and medical devices, including:
- Newly launched products
- Decades-old established brands
- Specialty pharmacy distributed products
- Hospital-based products
- Traditional pharmacy products
Development, Manufacturing, and Supply Agreements
As both emerging and established life-sciences companies continue to outsource development and manufacturing activities, contracting for these necessary activities has become critical. Our attorneys have experience representing and advising manufacturers and contract manufacturing and development organizations (CMDOs) on the appropriate structure and risk allocation involved in these complex commercial contracts.
Sales and Distribution Contracting: PBM, Wholesaler, and 3PL Contracting
Pharmaceutical and medical device sales and distribution is a complex commercial process. A successful sales and distribution strategy requires a network of interconnected operations necessitating commercial contracting arrangements with a variety of entities including:
- Pharmacy benefit managers (PBMs)
- Wholesale distributors
- Group purchasing organizations (GPOs)
- Third-party logistics (3PL) providers
- End customers.
Service fees and rebates offered in these arrangements must comport with a complex framework of healthcare fraud and abuse laws. Learn more about our Healthcare Compliance Practice. Our attorneys have experience advising companies throughout the sales and distribution contracting process.
Manufacturing, Distribution, and Wholesaler Licensure
At a federal level, the Verified-Accredited Wholesale Distributor (VAWD) program was implemented to help ensure the integrity and authenticity of prescription drug and device products. Additionally, each state has developed its own framework of drug distribution regulations and licensure requirements. These requirements impact not only wholesale distributors, but also manufacturers, virtual manufacturers, repackagers, and third-party logistics providers. In order to lawfully sell and distribute prescription drug or medical device products, companies must ensure that they have the appropriate licensure in place on a state-by-state basis. The specific licensure necessary is dependent on each company’s unique business operations and our attorneys have ample experience identifying and assisting clients in obtaining necessary licensure.
Open Payments (Sunshine Act) Compliance
Open Payments requires pharmaceutical and medical device manufacturers to report to the government certain payments or transfers of value (including meals) provided to healthcare providers. In addition, some states have their own additional restrictions and/or reporting requirements as well. These disclosure requirements implicate many common business operations (e.g. consulting arrangements, sales representative interactions, research agreements, etc.). Our attorneys routinely advise clients on how Open Payments may impact their business operations and assist clients with the preparation and submission of any required annual reports.
Contact Our Life Science Attorneys Today
If your organization needs assistance or counsel regarding the launch or ongoing commercialization of your drug, biologic, or medical device products, the life science attorneys at Kendall PC can help. Contact our office today online or at (484) 414-4093 to learn more about our services. We proudly serve small, emerging, and midsize businesses throughout the United States and across the globe.